Soft tissue repair devices, systems, and methods

ABSTRACT

Devices, systems and/or methods for repairing soft tissue, such as, a lacerated tendon. A repair device includes a frame having a tubular structure with a longitudinal length and struts at least partially defining the tubular structure. The frame includes a first portion and a second portion with an intermediate portion therebetween, each extending along the longitudinal length. The intermediate portion is configured to substantially maintain a fixed position and is configured to be positioned over first and second ends of the lacerated tendon to substantially maintain the first end abutted against the second end. The first portion and the second portion of the frame are configured to be positioned over separate portions of the tendon and configured to move and elongate along a length of the respective first portion and second portion of the frame as the portions of the tendon elongate.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. application Ser. No.13/953,709, filed on Jul. 29, 2013, which claims the benefit of U.S.Provisional Application No. 61/677,239, filed on Jul. 30, 2012, and U.S.Provisional Application No. 61/804,570, filed on Mar. 22, 2013, thecontents of which are each hereby incorporated by reference in theirentirety.

TECHNICAL FIELD

The present invention relates generally to soft tissue repair. Moreparticularly, the present invention relates to devices, systems, andmethods for repairing lacerated tendons.

BACKGROUND

Lacerated flexor tendon repair, as an example, is a procedure performedapproximately 145,000 times a year in the United States alone. For alltypes of tendons in the human anatomy, early post-operative mobilizationis beneficial to restoring maximal tendon function following injury andrepair. Adhesion formation is a common complication following tendonrepair, but can be reduced through motion rehabilitation programs. Bypreventing adhesion formation and gliding resistance, tendon healing maybe enhanced. However, the failure rate of tendon repairs is close to 30percent, primarily because of overloading at the repair site. Althoughan objective of tendon repair is to provide adequate strength forpassive and active motion during rehabilitation, it is important tomaintain a delicate balance between rehabilitative motion protocols andfatiguing the repair site.

A procedure for lacerated tendon repair is to use suture to mend the twoends of a tendon together using complex suture patterns. While thisprovides a good initial repair, the strength and quality of the repairmay quickly degrade with subsequent loading and mobilization. Althoughpostoperative therapy may be utilized to reduce adhesion, the resultingtension can induce gap formation or tendon rupture at the repair site,seriously impairing the outcome of the repair. Gapping at the repairsite has many negative effects, such as reduced repair strength, tendonrupture, and an increased probability for adhesion.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to various devices,systems and methods for repairing soft tissue in a body. For example, inone embodiment, a soft tissue repair device is provided configured tofuse a first tendon end and a second tendon end of a lacerated tendontogether. The soft tissue repair device includes a frame having atubular structure that defines an axis and a bore. The frame includesmultiple struts to at least partially define the tubular structure andis configured to receive the first tendon end and the second tendon end.The frame includes a first portion and a second portion with anintermediate portion therebetween. The intermediate portion isconfigured to be positioned over the first and second tendon ends tosubstantially maintain the first tendon end to abut the second tendonend. Further, the intermediate portion is configured to substantiallyresist elongation so as to maintain a substantially fixed positionrelative to the first and second tendon ends. The first portion and thesecond portion are configured to be positioned over separate portions ofthe tendon such that the frame is configured to elongate along a lengthof the respective first portion and the second portion of the frame asthe portions of the tendon elongate.

In one embodiment, the frame includes pad portions defining holestherethrough such that the pad portions are configured to receivestaples through the holes to secure the frame to the tendon. In anotherembodiment, the frame is secured to the tendon with staples. In anotherembodiment, the frame includes multiple tines extending from the firstportion and the second portion of the frame to engage and anchor to thetendon.

In another embodiment, the intermediate portion includes a wireconnecting the first portion and the second portion of the frametogether. In another embodiment, the frame is configured tosubstantially maintain the fixed position along a length of theintermediate portion of the frame.

In still another embodiment, the struts of the first portion and thesecond portion of the frame are moveable to an arcuate position. Inanother embodiment, the struts of the first portion and the secondportion of the frame are moveable to an arcuate position with the strutsof the intermediate portion substantially maintaining the fixedposition. In another embodiment, the struts of the first portion and thesecond portion include a multi-cellular structure.

In yet another embodiment, the frame includes a first side, a secondside, an upper side and a lower side, the first side being opposite thesecond side, the first and second sides including the struts to at leastpartially define the first and second sides, the struts extending tomultiple pad portions to at least partially define the upper and lowersides of the frame, each pad portion along the upper side being directlyopposite and facing another pad portion along the lower side of theframe. In another embodiment, the pad portions comprise holes extendingtherethrough configured to receive staples for securing the firstportion and the second portion of the frame to the tendon.

In accordance with another embodiment of the present invention, a repairdevice configured to fuse tissue at a repair site is provided. Therepair device includes a frame having multiple struts, the frameincluding a moveable portion and a stabilizing portion. The moveableportion is coupled to the stabilizing portion. The stabilizing portionof the frame extends over the repair site and the moveable portion ofthe frame is configured to be anchored to a portion of tissue separatefrom the repair site. With this arrangement, the moveable portion of theframe is moveable to elongate along a length of the moveable portion ofthe frame as the portion of tissue elongates with a load placed thereonand the stabilizing portion of the frame maintains a substantially fixedposition over the repair site.

In one embodiment, the moveable portion of the frame includes padportions defining holes therethrough such that the pad portions areconfigured to receive staples through the holes to secure the frame tothe tendon. In another embodiment, the frame is secured to the tendonwith staples. In another embodiment, the frame includes multiple tinesextending from the moveable portion of the frame for securing the frameto the tendon.

In another embodiment, the moveable portion of the frame is moveable toan arcuate position. In another embodiment, the moveable portion of theframe is moveable to an arcuate position as the portion of tissue towhich the moveable portion is anchored moves to an arcuate position.

In still another embodiment, the stabilizing portion comprises a wire.Further, in another embodiment, the struts of the frame comprise amulti-cellular structure.

In accordance with another embodiment of the present invention, a methodof repairing a lacerated tendon having a first tendon end and a secondtendon end. The method includes the steps of providing a frame having alongitudinal length and having a tubular structure defining an axis anda bore, the frame including multiple struts to at least partially definethe tubular structure, and the frame including a first portion and asecond portion with an intermediate portion therebetween; inserting thefirst tendon end into the first portion of the frame so that the firsttendon end is positioned within the intermediate portion of the frame;inserting the second tendon end into the second portion of the frame sothat the second tendon end is positioned within the intermediate portionof the frame and adjacent the first tendon end; and anchoring the firstportion and the second portion of the frame to the tendon; wherein theintermediate portion is configured to be positioned over the first andsecond tendon ends of the tendon to substantially maintain the firsttendon end abutted against the second tendon end such that the frame isconfigured to maintain a fixed position along a length of theintermediate portion of the frame; and wherein the frame is configuredto elongate along a length of the respective first portion and thesecond portion of the frame as portions of the tendon elongate with aload being placed on the tendon.

In one embodiment, the method step of anchoring includes anchoring thefirst portion and the second portion of the frame to the tendon withstaples. In another embodiment, the method step of anchoring includesanchoring the first portion and the second portion of the frame to thetendon with tines extending from the respective first portion and secondportion of the frame. In still another embodiment, the method step ofproviding includes providing the first portion and the second portion ofthe frame to be moveable to an arcuate position as the tendon moves to atendon arcuate position.

In accordance with another embodiment of the present invention, a softtissue repair device is provided configured to fuse a first tendon endand a second tendon end of a lacerated tendon together. The repairdevice includes a frame having struts defining a multi-cellularstructure along a length of the frame. The frame includes a firstportion and a second portion with an intermediate portion therebetween.The intermediate portion is configured to be positioned over the firstand second tendon ends of the tendon to substantially maintain the firsttendon end abutted against the second tendon end. The first portion andthe second portion are configured to be positioned over separateportions of the tendon and configured to move and elongate along thelength of the frame as the portions of the tendon elongate.

In another embodiment, the first and second portions of the frameinclude tines that extend therefrom such that the tines are configuredto engage the tendon. In another embodiment, the intermediate portion ofthe frame is configured to be positioned at least on opposing sides ofthe tendon. Further, in another embodiment, the first portion of theframe and the second portion of the frame are each configured to bepositioned at least on opposing sides of the tendon.

In another embodiment, the frame includes an upper frame portion and alower frame portion, the upper frame portion and the lower frame portionare each configured to extend with a substantially flat configurationand are substantially parallel relative to each other. The upper frameportion and the lower frame portion are coupled together with side frameportions.

In still another embodiment, the frame includes a cross-sectionalperiphery having a rectangular configuration. In yet another embodiment,the frame includes a cross-sectional periphery having an ovalconfiguration.

In another embodiment, the frame is moveable from a first non-engagingposition toward a second engaging position. The first non-engagingposition includes a cross-sectional periphery larger than the secondengaging position. Further, in one embodiment, the frame includes atleast one of a super-elastic material and a steel material.

In accordance with another embodiment of the present invention, a methodis provided of repairing a lacerated tendon having a first tendon endand a second tendon end. The method includes providing a frame havingstruts defining a multi-cellular structure along a length of the frame,the frame including a first portion and a second portion with anintermediate portion therebetween each extending along the length of theframe, the frame moveable between a first position and a secondposition; positioning the frame over the first tendon end and the secondtendon end such that the intermediate portion of the frame is disposedover the first tendon end abutting the second tendon end; moving theframe from the first position to the second position; engaging thetendon with tines extending from the first portion and the secondportion of the frame by moving the frame from the first position to thesecond position; and maintaining the first tendon end abutted to thesecond tendon end with the intermediate portion of the frame beingsubstantially non-elongatable while the first portion and the secondportion of the frame is elongatable along the length thereof so as tofacilitate the tendon to elongate with the frame attached thereto.

In another embodiment, the method step of positioning includespositioning the first tendon end and the second tendon end within theframe with a suture. In another embodiment, the method step of movingincludes engaging the tendon with tines extending from the first portionand the second portion of the frame. In yet another embodiment, themethod step of engaging includes engaging the tendon with tines orientedto extend at an acute angle relative to the length of the frame.

In a further embodiment, the method step of maintaining the first tendonend abutted to the second tendon end includes providing the intermediateportion of the frame with structure that substantially preventselongation along the length of the frame.

In another embodiment, the method step of moving the frame includescrimping portions of the frame to move and maintain the frame in thesecond position. In still another embodiment, the method includespositioning an applicator on the frame to hold the frame in the firstposition to facilitate the positioning the frame over the first tendonend and the second tendon end. In a further embodiment, the method stepof moving the frame includes removing the applicator from the frame sothat the frame automatically moves from the first position to the secondposition.

In accordance with another embodiment of the present invention, a softtissue repair device configured to fuse a first tendon end to a secondtendon end of a lacerated tendon is provided. The repair device includesa tubular frame including multiple interconnecting struts defining amulti-cellular tubular configuration. The tubular frame defines an axisand a longitudinal length extending along the axis. The tubular frame isconfigured to receive the lacerated tendon therein with the first tendonend insertable within a first open end defined in the tubular frame andwith the second tendon end insertable within a second open end definedin the tubular frame so that the tubular frame surrounds the laceratedtendon. The frame includes a first portion, a second portion, and anintermediate portion. The first portion and the second portion eachextending along the longitudinal length and are configured to elongatealong the longitudinal length so that as the tendon naturally elongatesthe first and second portions of the tubular frame also elongate withthe tendon. The intermediate portion extends along the longitudinallength and extends between the first portion and the second portion ofthe frame. The intermediate portion is configured to substantiallyresist elongation along the longitudinal length so as to maintain thefirst tendon end abutted against the second tendon end within thetubular frame.

In one embodiment, the tubular frame includes a cross-section with anoval configuration. In another embodiment, the tubular frame includes atleast one of a super-elastic material and a steel material.

In another embodiment, the struts of the intermediate portion extendsubstantially parallel with the axis of the tubular frame. In anotherembodiment, the struts of the first portion and the second portion ofthe tubular frame extend at an acute angle relative to the axis of theframe. In still another embodiment, the struts of the first portion andthe second portion of the tubular frame extend at a greater acute anglerelative to the axis of the frame than the struts of the intermediateportion extend relative to the axis of the frame. In yet anotherembodiment, the struts of the first portion and the second portioninclude a tapered portion so as to facilitate the struts to flex and thefirst and second portions of the frame to elongate along the length ofthe frame. In another embodiment, the struts of the first portion andthe second portion of the frame include a smaller width than the strutsof the intermediate portion of the frame.

In another embodiment, the tubular frame includes a first end and asecond end, the first end being opposite the second end, and the firstand second ends each including at least one crimp coupled thereto. Sucha tubular frame may include a super-elastic material and the crimp mayinclude a steel material.

In accordance with another embodiment of the present invention, a softtissue repair device configured to maintain a first end and a second endof a lacerated tendon adjacent each other is provided. The soft tissuerepair device includes a frame having struts defining a multi-cellularstructure and extending along a longitudinal length of the frame. Theframe also includes an upper frame portion, a lower frame portion, afirst side portion, and a second side portion. The upper frame portionincludes an upper first portion and an upper second portion with anupper intermediate portion therebetween. The lower frame portionincludes a lower first portion and a lower second portion with a lowerintermediate portion therebetween. The first side portion and the secondside portion each includes multiple side crimps, the upper frame portionand the lower frame portion coupled together with the side crimps. Withthis arrangement, the upper frame portion and the lower frame portionwith the side crimps coupled thereto are configured to cage or surroundthe lacerated tendon with the first tendon end and the second tendon endbeing positioned between the upper intermediate portion and the lowerintermediate portion of the frame. Further, the upper and lowerintermediate portions are configured to substantially resist elongationto substantially maintain the first tendon end abutted against thesecond tendon end, and the upper first and second portions and the lowerfirst and second portions of the frame are configured to engage thetendon and configured to elongate along the longitudinal length of theframe so as to facilitate the tendon to naturally elongate with theframe engaged to the tendon.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other advantages of the invention will become apparentupon reading the following detailed description and upon reference tothe drawings in which:

FIG. 1 is a top view of a repair device, depicting a tendon positionedwithin the repair device, according to an embodiment of the presentinvention;

FIG. 2 is a side view of the repair device shown in FIG. 1, accordingthe present invention;

FIG. 3 is an end view of the repair device shown in FIG. 1, depictingthe device in a non-engaging first position relative to the tendon,according to one embodiment of the present invention;

FIG. 4 is an end view of the repair device, depicting the device in anengaging second position relative to the tendon, according to anotherembodiment of the present invention;

FIG. 5 is an unassembled view of the repair device shown in FIG. 1,depicting various components of a frame including an upper frameportion, a lower frame portion, and side crimps, according to anembodiment of the present invention;

FIG. 5A is another embodiment of a side crimp, according to the presentinvention;

FIG. 6 is graph showing the strain along the length of the repairdevice, according to one embodiment of the present invention;

FIG. 7 is a top view of a repair device prior to being formed into atubular configuration, according to another embodiment of the presentinvention;

FIG. 7A is a side view of an end crimp, according to another embodimentof the present invention;

FIG. 8 is a simplistic perspective view of the repair device of FIG. 7,depicting the repair device formed into a tubular configuration with endcrimps at the ends of the repair device, according to another embodimentof the present invention;

FIG. 9A is a cross-sectional view of the repair device taken fromsection 9A of FIG. 9, according to an embodiment of the presentinvention;

FIG. 9B is the sectional view of the repair device shown in FIG. 9A,depicting an applicator expanding the repair device, according toanother embodiment of the present invention;

FIG. 9C is the sectional view of the repair device shown in FIG. 9A,depicting the applicator removed and conforming to a tendon positionedwithin the repair device, according to another embodiment of the presentinvention;

FIG. 10 is a top view of a repair device prior to being formed into atubular configuration, according to another embodiment of the presentinvention;

FIG. 11 is a simplistic perspective view of the repair device of FIG.10, depicting the repair device formed into a tubular configuration withend springs at the ends of the repair device, according to anotherembodiment of the present invention;

FIG. 12 is a perspective view of an adapter, according to an embodimentof the present invention;

FIG. 13 is a side view of a zip tie, according to another embodiment ofthe present invention;

FIG. 14 is a top view of another embodiment of a repair device,according to the present invention;

FIG. 14A is a side view of the repair device of FIG. 14, according toanother embodiment of the present invention;

FIG. 15 is a top view of the repair device, depicting first and secondapplicators inserted into opposite ends of the repair device, accordingto another embodiment of the present invention;

FIG. 16 is a top view of the repair device, depicting the repair devicebeing applied to a lacerated tendon by pulling the tendon ends into therepair device via suture needle loops, according to another embodimentof the present invention;

FIG. 17 is a top view of the repair device, depicting the repair devicepositioned over a lacerated tendon upon the applicators and sutureneedle loops are removed, according to another embodiment of the presentinvention;

FIG. 18 is a top view of the repair device, depicting an intermediateportion of the repair device synched to abut ends of the laceratedtendon, according to another embodiment of the present invention;

FIG. 19 is a perspective view of another embodiment of a repair device,depicting the repair device coupled to a lacerated tendon, according tothe present invention;

FIG. 20 is a perspective view of a first part of the repair device ofFIG. 19, depicting the repair device in a non-strained position,according to another embodiment of the present invention;

FIG. 21 is a side view of the first part of the repair device, depictinga side profile of the first part of the repair device, according toanother embodiment of the present invention;

FIG. 22 is a side view of the first part of the repair device, depictingthe first part of the repair device moved to an arcuate position,according to another embodiment of the present invention;

FIG. 23 is a perspective view of the first part of the repair device,depicting the repair device in a strained position as if loaded in anapplicator, according to another embodiment of the present invention;and

FIG. 24 is perspective view of the first part of the repair device,depicting the repair device positioned over a first tendon portion of alacerated tendon and staples in a non-stapled position, according toanother embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1-3, a soft tissue repair device 20 is depicted. Sucha repair device 20 may be sized and configured to approximate and fuse,for example, a lacerated tendon 10 together. The tendon 10, shown inoutline form, may be positioned in the repair device 20 such that afirst tendon portion 12 and a second tendon portion 14 with respectivefirst and second tendon ends 16, 18 are abutted against each other. Therepair device 20 may include a tubular configuration with opposing firstand second open ends 22, 24 to facilitate insertion of the first andsecond tendon portions 12, 14 therein such that the first and secondtendon ends 16, 18 are positioned at about a mid-point of the repairdevice 20. The repair device 20 may then be moved from a first,non-engaging position to a second, engaging position (FIG. 4).

The repair device 20 may be elongated with a longitudinal length 26 toexhibit the tubular configuration formed from multiple interconnectingstruts 28 to define a multi-cellular structure. The struts 28 of therepair device 20 may include structural characteristics that facilitateand resist elongation along portions of the length 26 of the repairdevice 20. For example, the repair device 20 may include a first portion30 and a second portion 32 with an intermediate portion 34 therebetween,each extending along the longitudinal length 28 of the repair device 20.The intermediate portion 34 may be configured to substantially resistelongation so that the first and second tendon ends 16, 18 positionedadjacent the intermediate portion 34 maintain their abuttedrelationship. The first and second portions 30, 32 of the repair device20 may be configured to engage the tendon 10 and elongate as the tendonelongates to facilitate functionality and a load placed upon the tendon10. Such elongation of the first and second portions 30, 32 andresistance to elongate at the intermediate portion 34 also substantiallyprevents overloading and, thus, gapping of the tendon 10 at the repairsite.

The repair device 20 may include a frame structure 36. The framestructure 36 may include an upper frame portion 38, a lower frameportion 40, a first side portion 42, and a second side portion 44, eachof which portions may be coupled together to form the tubularconfiguration with a cross-section having a square or rectangularconfiguration. The upper frame portion 38 and the lower frame portion 40may be substantially similar in structure as well as the first andsecond side portions 42, 44 may be substantially similar in structure.Further, the upper frame portion 38 and the lower frame portion 40 maybe formed from a variety of metallic materials, such as stainless steelor various alloys, but preferably a super elastic material, such asNitinol, to provide the desired structural strain characteristics. Thefirst and second side portions 42, 44 may also be formed from a metallicmaterial, such as stainless steel or Nitinol, or both, discussedhereafter.

With reference to FIG. 1, structural features and characteristics willnow be set froth for the upper frame portion 38, which will applyequally to the lower frame portion 40. The upper frame portion 38,similar to the lower frame portion (not shown), may include thebefore-described first portion 30 and the second portion 32 with theintermediate portion 34 therebetween each extending along thelongitudinal length 26 of the upper frame portion 38. The first portion30 extends along the longitudinal length 26 between the intermediateportion 34 and a first end 46 of the upper frame portion. Likewise, thesecond portion 32 extends along the longitudinal length 26 between theintermediate portion 34 and a second end 48 of the upper frame portion38. The intermediate portion 34 may be defined by outer rails 50extending substantially parallel to each other with intermediatestoppers 52 extending laterally between the outer rails 50. The stoppers52 may be in the form of laterally extending struts between the outerrails 50.

As previously set forth, the repair device 20 includes multipleinterconnecting struts 28 defining a multi-cellular structure. Forexample, the struts 28 of the first portion 30 and the second portion 32may extend, for the most part, at various angles relative to thelongitudinal length 26 of the upper frame portion 38. Such struts 28 ofthe first portion 30 and the second portion 32 may be sized andconfigured to facilitate elongation of the respective first and secondportions 30, 32 of the upper frame portion 38 such that the struts 28may flex. In one embodiment, the elongation of the first and secondportions 30, 32 of the upper frame portion 38 may gradually increasetoward the first and second ends 46, 48 of the upper frame portion 38,respectively. In another embodiment, the strainability or elongation ofthe first and second portion 30, 32 may increase toward their respectiveends in a gradient type manner. The struts 28 of the first and secondportions 30, 32 of the upper frame portion 38 may include asubstantially constant width along their respective longitudinal strutlengths. In another embodiment, the struts 28 may include a taperedportion along the longitudinal strut lengths to facilitate elongationalong the length 26 of the first and second portions 30, 32 of the upperframe portion 38. In still another embodiment, the struts 26 may includea radius along their respective length having a constant width or ataper to facilitate elongation of the first portion 30 and the secondportion 32.

The intermediate portion 34 of the upper frame portion 38 may includestruts 28 sized and oriented to substantially prevent elongation alongthe length of the intermediate portion 34. For example, the struts orthe rails along the length of the intermediate portion 34, beingsubstantially parallel, substantially limit the ability of theintermediate portion 34 to elongate. As known to one of ordinary skillin the art, other structural features and characteristics may beemployed to substantially limit elongation of the intermediate portion34 as well. The intermediate stoppers 52 may be sized and configured tosubstantially prevent trumpeting of the first and second tendon ends 16,18, or tendon portions adjacent thereto, from extending beyond oroutside of a plane of the upper and lower frame portions 38, 40.

With respect to FIGS. 1 and 3, the first and second portions 30, 32 ofthe upper and lower frame portions 38, 40 may include tines 54. Inanother embodiment, the intermediate portion 34 may also include tines54. The tines 54 may be sized and configured to aggressively engage andgrab the tendon 10 without damaging the tendon. The tines 54 may includea radius and a tapered portion 56 extending to a point 58. The tines 54may extend from an end portion of a given strut 28 or a node or juncturebetween adjacently extending struts 28, the tines 54 extending from thefirst and second portions 30, 32 of the frame structure 36. The tines 54of the upper frame portion 38 may extend with an orientation toward theintermediate portion 34 and downward. The tines 54 of the lower frameportion 40 may extend with an orientation toward the intermediateportion 34 and upward. Such orientation may be at an acute angle (seeFIG. 2) relative to the planes of the respective upper and lower frameportions 38, 40. Such orientation facilitates ready insertion into thetubular configuration of the repair device 20 as well as enhancesgrabbing the tendon to prevent migration therefrom once the repairdevice 20 is moved to the second engaging position (FIG. 4). Further,the tines 54 may be configured to flex slightly so as to a grab thetissue but upon tension being placed on the tendon 10 the tines 54 mayslightly move or bend to substantially prevent further damage to thetendon. In one embodiment, the tines 54 may extend substantiallyorthogonal relative to the plane of the respective upper and lower frameportions 38, 40. In another embodiment, the tines 54 may include one ormore barbs 59.

With respect to FIGS. 1, 2 and 5, the upper frame portion 38 and thelower frame portion 40 may include tabs 60. The tabs 60 may extend at orfrom a periphery 62 of each of the upper and lower frame portions 38,40. More particularly, the upper frame portion 38 includes a first side64 and a second side 66 each with at least two tabs 60 (one for each endof the first and second sides 64, 66) and, in this embodiment, five tabs60 for each of the first and second sides 64, 66. The tabs 60 on thefirst side 64 correspond and align with the tabs 60 on the second side66. The tabs 60 for the upper frame portion 38 may correspond and alignwith the number of tabs 60 for the lower frame portion 40. Each tab 60may include one or more openings 68 defined therein sized and configuredto couple to a side crimp 70.

The first side portion 42 and the second side portion 44 of the repairdevice 20 may each include at least two side crimps 70 with one at eachend to couple to the upper and lower frame portions 38, 40. In thisembodiment, the first side portion 42 and the second side portion 44each includes five side crimps 70. As previously set forth, the sidecrimps 70 may be sized and configured to couple to the upper and lowerframe portions 38, 40. For example, each side crimp 70 may include aclosed periphery with side arm portions 72 sized and configured tobuckle under a defined force. The side arm portions 72 may include oneor more weak portions 74 so as to facilitate the side crimps 70 todeform or buckle upon a force being placed thereto. The side crimps 70may define an upper opening 76 and a lower opening 78 with structure,such as, teeth 79 that extend in the openings sized and configured tolatch or couple to the tabs 60 of the upper and lower frame portions 38,40, respectively. In other words, the teeth 79 defining a portion of theupper opening 76 of one side crimp 70 may be sized to couple to one ofthe tabs 60 of the upper frame portion 38. Likewise, the structure orteeth 79 defining a portion of the lower opening 78 of the one sidecrimp 70 may be sized to couple to one of the tabs 60 of the lower frameportion 40. With this arrangement, the side crimps 70 couple the upperand lower frame portions 38, 40 to provide a tubular configuration toserve as a cage or box-like structure to position the tendon 10therethrough. The side crimps 70 may be formed from a metallic material,such as a stainless steel. In another embodiment, the side crimps may beformed from a super-elastic material, such as Nitinol.

The side crimps, as depicted in FIGS. 3 and 4, may serve to facilitatethe repair device 20 in maintaining its position at both the firstnon-engaging position and the second engaging position. In particular,in an embodiment where the side crimps 70 are, for example, stainlesssteel or the like, the structural characteristics of the side crimps 70maintain the upper and lower frame portions 38, 40 in the firstnon-engaging position so that the tendon 10 may be easily positionedwithin the repair device 20. Once the tendon 10 is appropriatelypositioned within the repair device 20, a force 71 may be placed uponthe repair device 20 to sandwich the tendon 10 within the repair device20 such that the tines 54 engage the tendon 10. Such force 71 bucklesthe side crimps 70 at the weak portions (not shown) defined therein tofacilitate the upper frame portion 38 to move closer to the lower frameportion 40. Due to the structural characteristics of, for example,stainless steel, the side crimps 70 maintain their buckled position to,thereby, maintain the repair device 20 in the second engaging position.

In another embodiment, as previously set forth, the side crimps 70 orfirst and second side portions 42, 44 of the repair device 20 may bemade from a super-elastic material. In such an embodiment, the first andsecond side portions 42, 44 (FIG. 1) may be constrained to an expandedposition with, for example, applicators (see FIGS. 9B and 12) at eachend to maintain the repair device in the first non-engaging position.Once the lacerated tendon 10 is inserted within the repair device 20,the applicators may be removed, after which, the first and second sideportions 42, 44 may then move toward a relaxed state such that therepair device 20 moves to the second engaging position. In the secondengaging position, the upper and lower frame portions 38, 40 move towardeach other such that the tines 54 extending from the upper and lowerframe portions 38, 40 engage the tendon 10.

In another embodiment, the first and second side portions 42, 44(FIG. 1) may be formed with a super-elastic material and a stainlesssteel material or the like. In this embodiment, side crimps 70 may beemployed at both ends of the first and second side portions 42, 44 ofthe repair device 20 with, for example, struts or crimps between theside crimps 70 at the ends. Such an embodiment may need the applicatorsto maintain the device 20 in the first non-engaging position. Once theapplicators are removed, the super-elastic struts or crimps pull theupper and lower frame portions 38, 40 closer together. A force may thenbe applied to the ends of the first and second side portions 42, 44 tobuckle the stainless steel side crimps 70 at the ends of the repairdevice 20.

Now referring to FIG. 5, one embodiment of an unassembled repair device20 is shown. Each of the upper and lower frame portions 38, 40 and theside crimps 70 may be laser cut from a flat sheet of metallic materialand, as such, the structural components are substantially flat andplanar with a low profile (See FIG. 3). As previously set forth, theupper and lower frame portions 38, 40 may be formed from a super-elasticsheet material, such as Nitinol. The side crimps may be formed from astainless steel sheet material and/or a super-elastic sheet material. Aspreviously set forth, the tines 54 of the upper and lower frame portions38, 40 may be oriented out-of-plane relative to the upper and lowerframe portions 38, 40 from which they respectively extend. As known byone of skill in the art, such orientation may be employed byheat-setting the tines 54 to a pre-determined orientation. Once the heatsetting of the tines 54 is completed, the repair device 20 may beassembled. For example, as set forth above, the lower opening 78 definedin each of the side crimps 70 may be coupled to the tabs 60 of the lowerframe portion 40. The upper opening 76 defined in the side crimps 70 maythen be coupled to the tabs 60 of the upper frame portion 38, asdepicted in FIGS. 1 and 2, to thereby assemble the repair device 20.

With respect to FIG. 5A, another embodiment of a side crimp 80 isdepicted. In this embodiment, the side crimp 80 may include a closedperiphery with arm portions 82 extending between an upper crimp portion84 and a lower crimp portion 86. The arm portions 82 may include weakportions 88 to facilitate buckling of the side crimp 80, as indicated byarrow 90, upon a force 92 being applied to the side crimp 80. As in theprevious side crimp embodiment, the side crimp 80 may include an upperopening 94 and a lower opening 96 defined in the upper crimp portion 84and lower crimp portion 86, respectively, configured to couple to tabs60 of the upper and lower frame portions 38, 40. As known by one ofordinary skill in the art, other structural configurations may beemployed for the side crimps 80 to facilitate crimping the repair device20 to the second engaging position.

With respect to FIG. 6, a graph, strain

vs. length X, representing the strainability along the length of therepair device 20 under typical tension/load forces that a tendon mayplace upon the repair device 20 is depicted. In addition, the graphdepicts the strainability of prior art devices, such as suturetechniques or other prior art devices, represented along reference line102. Further, the graph depicts the strainability of a native tendon ororiginal tendon that hasn't been damaged, shown along reference line104. Now with reference to FIGS. 1 and 6, the graph also representsvarious sections along length X that correspond with various portionsalong the length 26 of the repair device 20. For example, the graphdepicts a first section 106, a second section 108, and a third section110, which correspond to the first portion 30, the second portion 32,and the intermediate portion 34 of the repair device 20, respectively.The first section 106, corresponding to the first portion 30 of therepair device 20, depicts the strain

increasing (to the left) along the length 26 of the first portion 30from the intermediate portion 34 to the first end 46 of the firstportion 30. Likewise, the second section 108, corresponding to thesecond portion 32 of the repair device 20, depicts the strain

increasing (to the right) along the length 26 of the second portion 32from the intermediate portion 34 to the second end 48 of the secondportion 32. The third section 110, which corresponds to the intermediateportion 34 of the repair device 30, depicts minimized strainability anda substantially constant strain

. As depicted, the first and second portions 30, 32 of the repair device20 include structure to facilitate strainability or elongation along thelength 26 of the repair device 20. Such elongation of the first andsecond portions 30, 32 attached to a tendon 10 facilitates the tendon toelongate to allow the tendon to function similarly to that of the nativetendon while the intermediate portion 34 of the repair device 20substantially removes the load from the repair site of the laceratedtendon and prevents elongation to facilitate the healing process.

Now referring to FIGS. 7 and 8, another embodiment of a soft tissuerepair device 120 is provided. Similar to the previous embodiment, therepair device 120 includes a first portion 122 and a second portion 124with an intermediate portion 126 therebetween, each portion extendingalong a longitudinal length 128 of the repair device 120. The first andsecond portions 122, 124 include structure to facilitate elongation andstrainability along the length of the respective first and secondportions 122, 124. Also, the intermediate portion 126 may resist strainor elongation its length of the repair device 120. As such, the firstand second portions 122, 124 and intermediate portion 126 respondsimilar to respective first and second sections 106 and 108 and thirdsection in the graph of FIG. 6. Further, as in the previous embodiment,the repair device 120 may include interconnecting struts 130 defining amulti-cellular structure. The struts 130 extending over the length ofthe first and second portions 122, 124 may be sized and configured tofacilitate elongation along the length thereof. Further, the struts 130extending over the length of the intermediate portion 126 may be sizedand configured to substantially resist elongation. The intermediateportion 126 may include laterally extending struts 132. Such laterallyextending struts 132 may serve to cage the tendon (not shown) orsubstantially prevent the end portions of the severed tendon fromtrumpeting beyond the struts at the intermediate portion 126 of therepair device 120.

In this embodiment, the repair device 120 may primarily be a one piecemember and may be cut from a flat sheet of, for example, super-elasticmaterial, such as Nitinol or the like, and then formed into a tubularconfiguration. In the pre-formed configuration, the repair device 120may include a peripheral edge 134 with a first end edge 136, a secondend edge 138, a first side edge 140 and a second side edge 142. Thefirst and second end edges 136, 138 may include end coupling portions inthe form of tabs 144. The tabs 144 may define tab openings 146 sized andconfigured to couple to end crimps 148. The first and second side edges140, 142 may also include side coupling portions. Such side couplingportions may include side tabs 150 defining side openings 152. Once therepair device 120 is formed in the tubular configuration, the first sideedge 140 may be positioned to abut the second side edge 142 and coupledtogether via the side openings 152 of the respective first and secondside edges 140, 142 to provide a seam 154, shown in outline form in FIG.8. Such coupling may be employed with crimps, ties, zip-ties, or anyother suitable coupling mechanism as known in the art.

Now with reference to FIGS. 7, 7A and 8, one embodiment of an end crimp148 is provided. The end crimp 148 may include a c-shaped configuration.The end crimp 148 may include an upper end 156 and a lower end 158, eachend defining a notch configuration 160 sized and configured to couple tothe tab openings 146 defined in the tabs 144 at the first end edge 136and the second end edge 138 once the repair device 120 has been formedinto the tubular configuration. Further, the end crimps 148 may be sizedand configured to act as a clamp. As such, once a tendon is positionedwithin the repair device 120, the end crimps 148 may be sandwiched or,in other words, the upper end 156 and the lower end 158 may be movedcloser together to clamp down over the tendon. Such crimping or clampingmay minimize potential migration from the repair device when the tendonelongates under a load/tensional force. The end crimps 148 may be alaser cut from a flat sheet of metallic material, such as stainlesssteel or the like, or any other biocompatible material as known in theart that will substantially maintain a crimped or clamped position.

As previously set forth, the repair device 120 may be formed into atubular configuration from a flat sheet of, for example, super-elasticmaterial, such as Nitinol. Such may be employed by positioning the flatrepair device 120 within or around a jig and heat-setting the repairdevice 120 in the tubular configuration with the tines 162 orientedsubstantially orthogonally inward or at an acute angle to extend inwardand toward the intermediate portion 126, as known in the art. Thetubular configuration may include a cross-section with any appropriateconfiguration, depending on the particular soft tissue to be repaired.For example, most tendons include an oval cross-section and, as such,the cross-section of the tubular configuration may include a rectangularor oval configuration. However, some tendons include a circularcross-section and, as such, a square or circular configuration may beappropriate. As previously set forth, once heat-set and formed into thedesired configuration, the opposing first and second edges may then becoupled together to form the seam 154 and the end crimps 148 may then beassembled to the repair device 120.

With respect to FIGS. 9A, 9B, and 9C, the method steps for employing therepair device 120 with a tendon 10 are provided. For example, FIG. 9Adepicts a sectional view of FIG. 9, depicting the repair device 120 in afirst position and in its heat-set relaxed state. With respect to FIG.9B, prior to inserting, for example, a lacerated tendon 10 into therepair device 120, the repair device can be expanded. Such expansion maybe employed by inserting an applicator 164 at each end of the repairdevice 120 to move the repair device 120 to a second position or into anexpanded, stressed position. Once expanded, the tubular configuration isbroadened or provides a larger cross-sectional opening along the length(not shown) of the repair device 120. Such expanded position efficientlyfacilitates pulling a first tendon end and a second tendon end with, forexample, a suture (not shown), into the repair device 120 whileminimizing potentially damaging the tendon on the tines 162. Once thetendon 10 is appropriately positioned within the expanded repair device120, the applicators 164 may be removed from each end of the repairdevice 120. The repair device 120 will then automatically move towardits relaxed state or third position and conform around the tendon 10with the tines 162 engaging the tendon 10, as depicted in FIG. 9C. Theend crimps 148, shown in FIG. 8, may then be crimped or clamped tominimize potential migration of the tendon 10 from the repair device120.

Now with reference to FIGS. 10 and 11, another embodiment of a repairdevice 166 is provided. This embodiment is similar to the previousembodiment of FIGS. 7 and 8 in most all respects, except instead of endcrimps, this embodiment includes spring portions 168. The springportions 168 may be sized and configured to resist the ends of therepair device 166 widening under stresses the repair device 166 mayundergo while also allowing an applicator (not shown) to expand thetubular configuration in preparation for inserting and positioning atendon within the repair device 166. The spring portions 168 may extendgenerally from a periphery 176 of the repair device and, morespecifically, from a first end edge 170 and a second edge 172 with av-shaped configuration. Other configurations may also be employed tocontrol stresses within the tubular configuration of the repair device166. The spring portion 168 may include spring extensions 174 extendingfrom the periphery 176 of the repair device 166 and extend to a commonportion 178 to form the v-shaped configuration. The spring extensions174 may include an extension width 180 that is greater than a width 182of the struts 183 of the first portion 184 and the second portion 186 ofthe repair device 166. Struts 183 in the intermediate portion 185 may besimilarly sized or may be greater than the width 182 of the struts 183of the first and second portions 184, 186. With this arrangement, therepair device 166 may be formed from a single piece of, for example,super-elastic material, except for any potential side crimps forcoupling the first and second side edges 188, 190 to form the repairdevice 166 in the tubular configuration. Further, as in the previousembodiments, an important aspect of the present invention is that thefirst and second portions 184, 186 may elongate along the length of therepair device 166 and respond with a stainability characteristic similarto that shown in respective first and second sections of the graph ofFIG. 6. Likewise, the intermediate portion 185 structurally minimizesstrainablity and elongation along the length of the repair device 166 torespond similar to the third section of the graph of FIG. 6.

FIG. 12 depicts one embodiment of the before mentioned applicator 164that may be employed with either of the embodiments shown in FIGS. 8 and11. With respect to FIGS. 8, 11, and 12, the applicator 164 may includea first side rail 194 and a second side rail 196 with a bridge portion198 therebetween for joining the first and second side rails 194, 196.Each of the first and second side rails 194, 196 may include a taperedportion 202 to assist in the insertion of the applicator 164 in thetubular configuration of the repair device 120, 166. The first andsecond side rails 194, 196 each also include an upper edge 204 and loweredge 206. Upon inserting the applicator 164 into the tubularconfiguration, the tapered portion 202 assists in expanding the tubularconfiguration to expand the repair device 120 over the upper edge 204and lower edge 206 of the applicator 164, as depicted in FIG. 9B.

FIG. 13 depicts an enlarged view of a zip tie 210. The zip tie 210 isanother embodiment that may be employed for coupling ends together atthe before mentioned tabs of the repair device. The zip tie 210 mayreplace the various crimps discussed herein. The zip tie may include anelongated body 212 with a leading end 214 and a trailing end 216 with aback stop 218. The elongated body 212 may include tapered extensions 220extending therefrom such that the tapered extensions 220 taper towardsthe leading end 214. The zip tie 210 may be sized and configured suchthat the leading end 214 can be pulled through the side openings 152defined in the side tabs 150 of, for example, the tabs 150 of the firstand second side edges 140, 142 of the repair device 120 depicted in FIG.7. Once pulled through the side openings 152 and tightened to a desiredposition, the excess portion of the zip tie 210 may then be trimmed.

In another embodiment, in addition to, or instead of, thebefore-mentioned crimps or zip tie, sutures or a wire (not shown), suchas a Nitinol wire may be employed to maintain the repair device in theengaging position or second position. For example, in the embodimentshown in FIGS. 1 through 4, rather than employing the side crimps 70,the upper frame portion 38 and the lower frame portion 40 may be coupledtogether with a suture or flexible wire in a shoe-lace arrangement suchthat once the upper and lower frame portions 38, 40 are positioned overthe tendon 10 the suture or flexible wire may be synched to move theupper and lower frame portions 38, 40 to the second engaging position,as depicted in FIG. 4. The suture and/or wire may be pre-weaved throughthe appropriate tabs to move the respective frame portions to the secondposition or be laced through the tabs during the surgical procedure.Such suture and/or wire may be employed in any of the other embodimentsdescribed herein, for example, the suture and/or wire may be employed toreplace the end crimps 148 depicted in FIGS. 7A and 8.

With reference to FIGS. 14 and 14A, another embodiment of a repairdevice 310 is depicted. In this embodiment, the repair device 310includes a first portion 312, a second portion 314 and an intermediateportion 316 therebetween that define a bore 318 and an axis 320extending through the repair device 310 and along a longitudinal length324 of the repair device 310. The first and second portions 312, 314 maybe referenced as moveable or elongateable portions and the intermediateportion 316 may be referenced as a stabilizing portion sized andconfigured to resist elongation. In other words, the first and secondportions 312, 314 may be configured to move and elongate as a load isplaced on the tendon while the intermediate portion 316 may beconfigured to stabilize tendon ends to be abutted and maintained againsteach other in a substantially fixed position such that the intermediateportion is also in a substantially fixed position relative to the tendonends and resists elongation along a length of the intermediate portion.Further, in this embodiment, the first portion 312 and the secondportion 314 are two separate tubular frame structures connected with oneor more wires 322 interlaced through apertures (not shown) defined atends the first portion 312 and second portion 314 of the repair device310, the one or more wires 322 defined as the intermediate portion 316.As will be discussed in further detail below, the longitudinal length324 of the repair device 310 may be minimized upon application of therepair device 310 to a first tendon portion and a second tendon portion(not shown) such that the intermediate portion 316 will be tightenedover lacerated ends of the tendon and minimized along its length.

The first and second portions 312, 314 of the repair device 310 may belaser cut from, for example, a metallic material, such as stainlesssteel or a super-elastic material. For example, in one embodiment, therepair device may be cut from a flat sheet or tube of super-elasticmaterial, such as Nitinol or the like. In the example of the superelastic material, once laser cut, the components of the repair devicemay undergo various processes, such as electro-polishing and, ifnecessary, heat-set in, for example, a heated sand bath to a desiredposition, as known to one of ordinary skill in the art. Further, thewire may be a metallic material, such as Nitinol or stainless steel.

The first portion 312 may include multiple interconnecting struts 326 todefine a multi-cellular structure. The interconnecting struts 326 mayextend from the intermediate portion 316 to a first end 328 of therepair device 310 and extend in a tubular configuration to define aportion of the bore 318 extending therethrough. Likewise, the secondportion 314 may include the multiple interconnecting struts 326 todefine a multi-cellular frame structure and extend from the intermediateportion 316 to a second end 330 of the repair device 310, extending witha tubular configuration to define a portion of the bore 318 of therepair device 310.

Each of the first portion 312 and the second portion 314 may includetines 332 or hooks extending from nodes 334 or junction points of theinterconnecting struts 326. The nodes 334 or a node may be defined asthe junction of one strut 326 interconnecting to one or more adjacentstruts 326, the tines 332 extending from such nodes 334, similar to thatset forth in previous embodiments. The tines 332 may extend inwardtoward the axis 320 of the repair device 310. In another embodiment, thetines 332, of both the first portion 312 and the second portion 314, mayextend inward toward the axis 320 and toward the intermediate portion316 such that the tines 332 of the first portion 312 are oriented in afirst direction and the tines of the second portion 314 are oriented ina second direction, similar to that set forth in previous embodiments.In one embodiment, each node 334 may include one or more tines 332extending therefrom. In another embodiment, the tines 332 may extendfrom nodes 334 along an upper portion 336 and a lower portion 338 of therepair device 310.

Now with reference to FIGS. 15 through 18, the steps for applying andsecuring the repair device 310 to a lacerated tendon will now bedescribed. With respect to FIG. 15, the repair device 310 may be removedfrom sterile packaging (not shown) along with, for example, two needlepoint suture loops 340, 342 (see FIG. 16). The repair device 310 may bepre-loaded with the first portion 312 over a first applicator 344 andthe second portion 314 over a second applicator 346 (see also thedescription of FIG. 12 of one example of an applicator). Otherwise, thephysician may load the first and second portions 312, 314 of the repairdevice 310 to the first and second applicators 344, 346, respectively.With the repair device 310 positioned over the first and secondapplicators 344, 346, the repair device 310 is expanded to anorientation or shape that radially enlarges the bore 318 of the repairdevice 310 to readily facilitate inserting the lacerated tendon into therepair device 310.

As depicted in FIGS. 16 and 17, the first and second needle point sutureloops 340, 342 may be passed through and secured to the first tendonportion 305 and a second tendon portion 307, respectively, employingsuturing techniques as known to one of ordinary skill in the art. Therepair device 310 may then be positioned between the first and secondtendon portions 305, 307. The first tendon portion 305 may then bepulled through the bore 318 of the first portion 312 of the repairdevice 310 by pulling the secured first suture loop 340 into the bore sothat the end of the first suture loop 340 is passed through the wires322 of the intermediate portion 316, as depicted. Similarly, the secondtendon portion 307 may then be pulled into the bore 318 of the secondportion 314 of the repair device 310 via the second suture loop 342.Once the first tendon portion 305 is positioned within the bore 318 ofthe first portion 312 of the repair device 310, the first applicator 344can be removed and the first suture loop 340 may be removed or cut fromthe first tendon portion 305. Likewise, upon the second tendon portion307 being positioned within the bore 318 of the second portion 314 ofthe repair device 310, the second applicator 346 and second suture loop342 may be removed, as depicted in FIG. 17. Upon the first and secondapplicators 344, 346 being removed from the first and second tendonportions 305, 307, the radial dimension or height of the bore 318automatically is minimized along a length of the first and secondportions 312, 314 of the repair device 310 such that the tines 332 (FIG.14A) engage the tendon to anchor the repair device thereto.

At this juncture, with reference to FIGS. 17 and 18, the one or morewires 322 of the intermediate portion 316 may be pulled by thephysician, as indicated by arrows 350, so as to pull the first portion312 and the second portion 314 closer to each other. Further, suchpulling of the one or more wires 322 pulls respective ends of the firstand second tendon portions 305, 307 against each other in an abuttedarrangement. The one or more wires 322 may include one or more swages352 or crimps that can be tightened down over the one or more wires 322to maintain the first and second tendon portions 305, 307 against eachother. With this arrangement, the intermediate portion 316 of the repairdevice 310 substantially maintains the ends of the respective first andsecond tendon portions 305, 307 in the abutted arrangement while thefirst portion 312 and the second portion 314 is anchored or harnessed tothe lacerated tendon via the tines 332.

With respect to FIGS. 6 and 18, similar to previous embodiments, themulti-cellular frame structure of the first portion 312 and secondportion 314 of the repair device 310 may elongate upon a load beingplaced upon the tendon while the intermediate portion 316 substantiallyprevents elongation of the ends of the first and second tendon portions305, 307, maintaining such ends to in the abutted arrangement. Forexample, similar to previous embodiments, the structural characteristicsof the interconnecting struts 326 extending along the first portion 312and the second portion 314 of the repair device 310 may be sized andconfigured (e.g., by tapering along their lengths or varying thethickness of the struts or varying the angle of the struts, arcuateportions along lengths of struts (cell configuration), materialproperties, etc.) to facilitate elongation upon a load being placed uponthe tendon. In this manner, the first portion 312 and the second portion314 may strain or elongate along their respective lengths similar tothat depicted in sections 106 and 108, respectively, of thestrain-length graph of FIG. 6. Similarly, the intermediate portion 316,made of one or more wires 322 interlaced with the first and secondportions 312, 314 of the repair device 310, may be sized and configuredto substantially prevent or resist strain or elongation along theintermediate portion 316 of the repair device 310, similar to thatdepicted in section 110 of the strain vs. length graph of FIG. 6. Withthis arrangement, the repair device 310 can facilitate elongation of aloaded tendon while also maintaining the lacerated ends of the first andsecond tendon portions 305, 307 in the abutted arrangement.

Now with reference to FIGS. 19-22, another embodiment of a repair device410 configured to harness and repair a lacerated tendon 403 is depicted.This embodiment is similar to the previous embodiment in that the repairdevice 410 includes separate portions coupled together, such as a firstpart 426 and a second part 427 with one or more wires 418 coupling thefirst part 426 to the second part 427, except this embodiment may notinclude integrally formed anchors/tines, but rather, the repair device410 of this embodiment may employ separate and discrete anchoringcomponents, such as staples 472 (FIG. 22), to anchor the repair device410 to the tendon 403.

With respect to FIG. 19, the repair device 410 may include a firstportion 412, a second portion 414 and an intermediate portion 416extending between the first and second portions 412, 414, theintermediate portion 416 including, among other portions, the one ormore wires 418. As in the previous embodiments, the first and secondportions 412, 414 may be referenced as moveable or elongateable portionsand the intermediate portion 416 may be referenced as a stabilizingportion that is sized and configured to resist elongation. In otherwords, the first and second portions 412, 414 may be configured to moveand elongate (or even move to an arcuate position) as a load is placedon the tendon while the intermediate portion 416 may be configured tostabilize tendon ends to be abutted and maintained against each other ina substantially fixed position with the intermediate portion 416 also ina substantially fixed position relative to the tendon ends such that theintermediate portion 416 resists elongation along a length of theintermediate portion.

Further, the first part 426 may define the first portion 412 and aportion of the intermediate portion 416. Similarly, the second part 427may define the second portion 414 and another portion of theintermediate portion 416. The first portion 412 and the second portion414 may be sized and configured to be positioned over a first tendonportion 405 and a second tendon portion 407, respectively, and theintermediate portion 416 of the repair device 410 may be configured tospan and be positioned over abutted ends 409 and end portions of thelacerated tendon 403. As in previous embodiment, the repair device 410may define a bore 420 and an axis 422 each extending longitudinallythrough the repair device 410 to receive the lacerated tendon 403. Withthis arrangement, the repair device 410 may act as a harness typestructure for a lacerated tendon 403 with first and second portions 412,414 that dynamically move relative to the variable loads and movementmade by the tendon and with the intermediate portion 416 controlling andminimizing movement of the abutted ends 409 of the lacerated tendon 403.

The structure of the repair device 410 may include various struts,extensions, and/or portions, some of which may define a multi-cellularstructure, each having a particular function described in detail herein.Further, the first part 426 and the second part 427 of the repair device410 may be laser cut from, for example, a tube of super-elasticmaterial, such as Nitinol. As such, the first and second parts 426, 427of the repair device 410 may each be its own unitary and monolithicstructure having been made from a single piece of tube. Once laser cut,the first and second parts 426, 427 of the repair device 410 may undergovarious processes, such as electro-polishing and, if necessary, heat-setin, for example, a sand bath to a desired position, as known to one ofordinary skill in the art. The one or more wires 418 may be metallic,such as Nitinol or stainless steel, or any other suitable andbiocompatible material. In another embodiment, the first and secondparts 426, 427 of the repair device may not be separated as twocomponents, but rather, formed from a single tube of material and formedas a unitary, seamless, monolithic structure

With respect to FIGS. 20 and 21, for simplification purposes, only thefirst part 426 defining the first portion 412 and a first intermediateportion 424 of the repair device 410 is depicted, although the secondpart 427 (FIG. 19) may be a mirror image of the first part 426 and maybe substantially similar in functionality, parts, and portions in allrespects. The first part 426 of the repair device 410 may include afirst side 428, a second side 430, an upper side 432 and a lower side434 defining the axis 422 and the bore 420 extending axiallytherethrough and extending between a first end 436 and a second end 438of the first part 426. The first side 428 and the second side 430 mayeach include a tree-like structure having a trunk 440 and multiplebranches 442. Each trunk 440 of the first part 426 of the repair device410 may define the first intermediate portion 424. Further, each trunk440 may include a width 444 that is larger than a branch width 446. Eachtrunk 440 may extend between the second end 430 and the branches 442 or,otherwise referred to, the first portion 412 of the repair device 410,the second end 438 of the first part 426 defining an eyelet 448 forlacing the before-mentioned one or more wires 418 (FIG. 19). Further,the trunk 440 may be proportionately smaller or larger in lengthrelative to the first portion 412 than that which is depicted.

As previously set forth, each of the first and second sides 428, 430 mayinclude the trunk 440 with multiple branches 442, each extending with asubstantially similar profile and pattern. For example, the branches 442may include a first branch set 450, a second branch set 452 and a thirdbranch set 454, each extending from a junction point 456. The firstbranch set 450 may extend directly from the trunk 440 or the junctionpoint 456 between the trunk 440 and the first branch set 450. The firstbranch set 450 may include an upper branch 442 a, a middle branch 442 band a lower branch 442 c. The upper branch 442 a may extend at an anglerelative to the middle branch 442 b, extending upward and toward thefirst end 436 of the first part 426 of the repair device 410. The lowerbranch 442 c may extend at a similar angle, but a mirror image of theupper branch 442 a, extending downward and toward the first end 436 ofthe first part 426 of the repair device 410. The middle branch 442 b mayextend toward the first end 436 and parallel with the axis 422 of therepair device 410. Further, the middle branch 442 b of the first branchset 450 may extend toward the junction point 456 of the second branchset 452. The first branch set 450 and the second branch set 452 mayextend similar to each other, the second branch set 452 including themiddle branch 442 b that extends to the third branch set 454. In oneembodiment, the third branch set 454 may include the upper branch 442 aand the lower branch 442 c, without the middle branch 442 b. In anotherembodiment, the third branch set 454 may include the middle branch 442 bthat extends to a fourth branch set (not shown). This may be repeatedwith additional branch sets depending on the desired extending branchsets for a given length of the first part 426 of the repair device 410.

As previously set forth, each of the first side 428 and second side 430of the first part 426 of the repair device 410 may extend similarly toeach other with respective trunks 440 and branches 442. With thatstated, the first side 428 and the second side 430 may be coupled toeach other with lateral extensions 458 or pad portions extending betweenrespective upper branches 442 a and lower branches 442 c of each of thebranch sets. For example, the upper branch 442 of the first branch set450 on each of the first side 428 and the second side 430 of the firstpart 426 of the repair device 410 may extend to one lateral extension458 or, more specifically, an upper pad portion 460. Likewise, the lowerbranch 442 c of the first branch set 450 on each of the first side 428and second side 430 of the repair device 410 may extend to anotherlateral extension 458 or a lower pad portion 462. Each branch set maysimilarly extend with its upper branch 442 a and lower branch 442 c toan upper pad portion 460 and a lower pad portion 462, respectively. Theupper and lower pad portions 460, 462 may at least partially define theupper side 432 and the lower side 434 of the first part 426 of therepair device 410. Each pad portion may include an inner surface 464 andan outer surface 466, the inner surface 464 facing the axis 422 of therepair device 410. Further, the upper pad portion 460 may directly facethe lower pad portion 462. For example, the upper branch 442 a of thefirst branch set 450 extends to the upper pad portion 460 and the lowerbranch 442 c of the first branch se 450 t extends to the lower padportion 462 such that the inner surfaces 464 of the upper pad portion460 and the lower pad portion 462 correspond and face each other. Theupper and lower pad portions 460, 462 of the second and third branchsets 452, 454 may be similarly arranged. In addition, the outer surfaces466 of the upper and lower pad portions 460, 462 may face directly awayfrom each other. The inner and outer surfaces 464, 466 of each of thepad portions may be substantially planar. In one embodiment, the innerand/or outer surfaces 464, 466 may include one or more atraumatic tabsthat may protrude from the surfaces for aligning purposes.

Each of the upper and lower pad portions 460, 462 may include one ormore through holes 468 and one or more indents 470 in the form of anotch extending through a portion of the pad. For example, each padportion may define two pair of holes 468 extending through the padportion such that the holes 468 of the upper pad portion 460 correspondand are aligned with the holes 468 of the corresponding lower padportion 462. Further, the outer surface 466 (or the inner surface) ofeach of the pad portions may include the indents 470 or atraumatic tabssized and configured to align each upper pad portion 460 with itscorresponding lower pad portion 462 when expanded with, for example, anapplicator (not shown). In the case of employing indents 470 foraligning purposes, the applicator may include tabs that may fit andalign within the indents 470 to properly align the device within theapplicator. In the case of tabs, the applicator may have correspondingtabs or indents to facilitate proper alignment of the repair devicewithin the applicator. Further description of the holes 468 and indents470 or notches will be provided hereafter.

With respect to FIGS. 20 and 22, as previously set forth, the firstintermediate portion 424 or trunk 440 includes a width 444 greater thanthe branch width 446 of each middle branch 442 b and may also be greaterthan a width of each upper and lower branches 442 a, 442 c. The width444 of the trunk 440 may be sized and configured to stabilize the endsof the lacerated tendon 403 (see FIG. 19). Further, such width 444 maybe sized to minimize bending of the trunk so that movement of a portionof the tendon 403 situated along the first intermediate portion 424 isalso minimized. With that being said, the middle branches 442 bextending along the first portion 412 of the repair device 410 may besized and configured to facilitate bending or to facilitate the firstportion 412 of the repair device 410 to be moveable to an arcuateposition or moveable with a tight radial turn, such as up to a 90 degreeangle. Such bending may be useful depending on the type of tendon 403being repaired, such as a digit tendon along one's finger. Further, theupper and lower branches 442 a, 442 c of each branch set may be sizedand configured to bend and correspond with the arcuate position of themiddle branch 442 b. Further, the upper and lower branches 442 a, 442 cof each branch set may be sized and configured to facilitate elongationof the first portion 412 as a load is placed upon the tendon 403 towhich the first portion 412 is attached and the tendon naturally wantsto elongate and/or move along a bend. As in previous embodiments, as thefirst portion 412 elongates and facilitates elongation of the tendon403, the intermediate portion 416 or first intermediate portion 424substantially prevents elongation to minimize movement at the ends ofthe lacerated tendon 403. Further, as in previous embodiments, the firstportion 412 may elongate with a strain gradient similar to that shown inthe corresponding section 106 of FIG. 6. Similarly, the intermediateportion 416 of the repair device 410 may be sized and configured tosubstantially prevent or resist strain and elongation along that portionof the repair device 410 similar to that shown in section 110 of FIG. 6and, therefore, substantially prevents separation of the ends of thelacerated tendon 403. As set forth previously, the first part 426 ofrepair device 410 is a mirror image of a second part 427 of the repairdevice 410, as depicted in FIG. 19 and, therefore, may structurallybehave in a similar manner.

With respect to FIG. 23, the first part 426 of the repair device 410 isdepicted in a strained position. It is noted that the second part (notshown) of the repair device 410 may be similarly moved to the strainedposition. The first part 426 of the repair device 410 may be moved tothe strained position with an applicator (not shown) similar to thatprovided in previous embodiments. In the strained position, the upperand lower branches 442 a, 442 c of each branch set may be moved toextend upward and downward, respectively, toward the respective upperside 432 and lower side 434 of the repair device 410. In this manner,the bore 420 extending through the first portion 412 of the repairdevice 410 may be enlarged to readily facilitate pulling a first tendonportion (not shown) through the bore 420, similar to that depicted inthe previous embodiment.

With reference to FIG. 24, the first part 426 of the repair device 410positioned over the first tendon portion 405 is depicted with staples472 in a non-stapled position. Once the first tendon portion 405 ispulled through the bore 420 of the first part 426 of the repair device410, the repair device 410 may be anchored to the lacerated tendon 403with, for example, staples 472. The staples 472 may be applied via anapplicator (not shown) with a staple cartridge (not shown) that may beintegrated with the applicator. The staples 472 are depicted in anon-stapled position as if positioned in the staple cartridge. In thenon-stapled position, the staples 472 may be disposed directly over theholes 468 defined in each of the upper pad portions 460. The staples 472may include an elongated u-shaped configuration with free ends 474 andlegs 476. The staples 472 may be properly aligned with the holes 468with indents 470 or notches defined in the upper and lower pad portions460, 462 such that the applicator/staple cartridge may includecorresponding structure, such as tabs to ensure proper alignment of therepair device 410.

To anchor the repair device 410 to the lacerated tendon 403, the staplecartridge may be compressed so that the free ends 474 pass through theholes 468 in the upper pad portions 460 and continue downward, passingthrough the tendon 403 and through corresponding holes 468 in the lowerpad portion 462. The free ends 474 may fold over along the outer surface466 of the lower pad portions 462. With this arrangement, the repairdevice 410 may be coupled to the lacerated tendon 403. Once the staples472 are in the stapled position to anchor the repair device 410 to thetendon 403, the applicator/staple cartridge (not shown) may be removedand the one or more wires 418 (FIG. 19) may be synched over the ends ofthe lacerated tendon 403 and held tight with swages or crimps (notshown), similar to that described and depicted in FIGS. 17 and 18 of theprevious embodiment. In this manner, the repair device 410 may beanchored to the lacerated tendon 403 by employing separate and discretecomponents relative to the repair device, such as the staples 472.

In another embodiment, the repair device 410 may include tines extendingfrom the inner surface 464 of the upper and lower pad portions 460, 462of the repair device 410 to act in conjunction with the staples 472 toanchor or harness the repair device 410 to the lacerated tendon 403. Inanother embodiment, the repair device 410 may include tines or hooks(without the use of staples) for anchoring or harnessing the repairdevice 410 to the lacerated tendon 403. Further, in another embodiment,the first part 426 and the second part 427 of the repair device 410 maybe formed as a single monolithic structure from a single tube, similarto that described in previous embodiments. It is also contemplated thatthe present invention of providing a moveable portion of the repairdevice to be moveable with tissue while another portion of the repairdevice is substantially fixed adjacent a repair site to facilitateproper healing at the repair site, but also providing the mobility foroptimal tissue healing may also be applied to other structures in thebody, such as tissue-to-bone and bone-to-bone structures. Such a devicemay include a tubular structure, a partially tubular structure, and/or aplate like structure including multiple interconnecting struts that maydefine a multi-cellular structure.

Other examples of soft tissue repair devices, methods, and systems areset forth in U.S. patent application Ser. No. 12/783,507, filed on May19, 2010, entitled TISSUE FIXATION, and U.S. patent application Ser. No.13/021,653, filed on Feb. 4, 2011, entitled TISSUE STABILIZATION SYSTEM,and U.S. patent application Ser. No. 13/021,651, filed Feb. 4, 2011,entitled SYSTEM FOR TISSUE FIXATION TO BONE, the disclosures of whichare incorporated by reference herein in their entirety.

While the invention may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the invention is not intended tobe limited to the particular forms disclosed. Rather, the inventionincludes all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the followingappended claims.

What is claimed is:
 1. A method of repairing a lacerated tendon having afirst tendon end and a second tendon end, the method comprising:providing a frame having a longitudinal length and having a tubularstructure defining an axis and a bore, the frame including multiplestruts to at least partially define the tubular structure, and the frameincluding a first portion and a second portion with an intermediateportion therebetween; inserting the first tendon end into the firstportion of the frame so that the first tendon end is positioned withinthe intermediate portion of the frame; inserting the second tendon endinto the second portion of the frame so that the second tendon end ispositioned within the intermediate portion of the frame and adjacent thefirst tendon end; and anchoring the first portion and the second portionof the frame to the tendon; wherein the intermediate portion isconfigured to be positioned over the first and second tendon ends of thetendon to substantially maintain the first tendon end abutted againstthe second tendon end such that the frame is configured to maintain afixed position along a length of the intermediate portion of the frame;and wherein the frame is configured to elongate along a length of therespective first portion and the second portion of the frame as portionsof the tendon elongate with a load being placed on the tendon.
 2. Themethod according to claim 1, wherein the anchoring comprises anchoringthe first portion and the second portion of the frame to the tendon withstaples.
 3. The method according to claim 1, wherein the anchoringcomprises anchoring the first portion and the second portion of theframe to the tendon with tines extending from the respective firstportion and second portion of the frame.
 4. The method according toclaim 1, wherein the providing comprises providing the first portion andthe second portion of the frame to be moveable to an arcuate position asthe tendon moves to a tendon arcuate position.